Clinical Trial Administrator
Title:
Clinical Trial AdministratorCompany:
Ipsen Pharma (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.
Job Description:
Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?
Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.
Why Ipsen?
Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.
Employee Care: We care for our employees, who are the ambassadors making a real difference.
Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.
Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
About the Role
The Clinical Trial Administrator assists in the delivery of Clinical Development objectives and achieve Clinical Operation Excellence, mainly by supporting the Clinical Research Manager (CRM)/Clinical Project Manager (CPM) in administrative activities within the conduct of the clinical studies
Main Responsibilities
Perform and/or coordinate, on request, some non-administrative specific clinical study tasks under the direction of the CRM/CPM and Program Director/Head of ClinOps
Be responsible for settingup, monitoring verifying and archiving the clinical Trial Master File (TMF)
In charge of the Ipsen electronic TMF (and/or paper TMF, if applicable) set-up and administration.
Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners. protocol.
Be responsible for followup and review of financial documents, in collaboration with CRM/CPM
Create and update financial information within the Ipsen financial system (K2, SAP, …) (Internal Order, Purchase Order, goods receipt & invoices), or managed by a dedicated position, if available.
Create and follow-up of the clinical study Commitment Requests within the Ipsen dedicated tool (K2).
Create and update the specific clinical study budget trackers.
Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM.
Responsible for tracking, collecting and disclosure of expenses in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US)
Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect).
Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
Check the data received from the CROs with the support of the CRM/CPM.
Responsible for data entry and status updates within the Ipsen Clinical Trial Management System (CTMS)
When assigned on a study, get access to the study record in eCTMS.
Check the eCTMS study data using the Clinical Operations Reporting (with the support of CRM/CPM for the monthly report purposes.
Coordinate and conduct in-house and external clinical operations activities
Generate contract templates within the Ipsen dedicated system (i-CAP), followup until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts.
Collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorisation (LOA), Confidentiality Disclosure Agreement (CDA), Kbis…
Qualifications
Bachelor’s life science degree or administrative
Strong experience in clinical study environment within CRO or Pharmaceutical company.
Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
English fluency
Computer literacy
Ability to travel as required with the needs of the role, up to approximately 25% of the time.
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